MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF SYRINGE BODY; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 800247

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2015

Event Type  malfunction  

Event Description

It was reported that the nipple tip of the syringe was leaking.Therefore, could not build the appropriate pressure required to expand the implant.

Manufacturer Narrative

Visual inspection; functional inspection; material analysis; device history review; complaint history review; risk assessment the returned was confirmed to leak upon functional inspection.It was found that the syringe cannot hold the required pressure.No relevant manufacturing issues were identified as all released units met stryker specifications.The plausible root cause of the reported event is likely multifactorial in nature.

Event Description

It was reported that the nipple tip of the syringe was leaking.Therefore,could not build the appropriate pressure required to expand the implant.

• Brand Name: ACCULIF SYRINGE BODY
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5318095
• MDR Text Key: 34357359
• Report Number: 3004024955-2015-00116
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 800247
• Device Lot Number: 03181402-017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1